400 mg film-coated tablets
raltegravir
1. What Isentress is and what it is used for
What Isentress is
Isentress contains the active substance raltegravir. Isentress is an antiviral medicine used against the human immunodeficiency virus ( HIV ). This is the virus that causes Acquired Immune Deficiency Syndrome ( AIDS ).
How Isentress works
HIV – the virus et produces an enzyme called HIV integrase, which helps the virus et multiplying in the cells of the body. Isentress prevents the enzyme from working. When Isentress is used in combination with other medicines, this can reduce the amount of HIV in the blood (so-called “viral load”) and increase the number of CD4 cells (a type of white blood cell that plays an important role in the human immune system to fight infection ). Reducing the amount of HIV in your blood can help keep your immune system healthy. This means that your body can more easily fight infection with you.
When to use Isentress
Isentress is used to treat those infected with HIV. Your doctor has prescribed ISENTRESS to help keep your HIV – infection under control.
2. What you need to know before taking Isentress
Do not take Isentress:
- if you are allergic to raltegravir or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Isentress.
Remember that Isentress does not cure HIV – infection. This means that you can continue to get infections or other diseases that are associated with HIV. You should continue to see a doctor regularly while taking this medicine.
Mental disorders
Tell your doctor if you have a history of depression or mental illness. Depression, including suicidal ideation and suicidal ideation, has been reported in some patients using this medicine, especially in patients with a history of depression or mental illness.
Skeletal problems
Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index ( BMI ). Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. If you experience any of these symptoms, tell your doctor.
Liver problem
Tell your doctor, pharmacist, or nurse if you have a history of liver problems, including hepatitis B or C. Your doctor may want to evaluate the severity of your liver disease before deciding if you can take this medicine.
Transmit HIV to others
HIV – infection is spread by contact with blood or sexual contact with a person who has HIV. You can still transmit HIV infection while taking this medicine, although the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.
Infection is
Tell your doctor, pharmacist, or nurse immediately if you notice any symptoms of infection, such as fever and/or malaise. In some patients with advanced HIV – infection and a history of opportunistic infection, you ( infection s due to weakened immune system), signs and symptoms of inflammation from this earlier infection may occur soon after anti- HIV started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infection. you who may have existed without any obvious symptoms.
In addition to opportunistic infection, you can autoimmune disorders (conditions in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.
Muscle problem
Contact a doctor, pharmacist, or nurse immediately if you experience unexplained muscle pain, tenderness, or weakness during treatment with this medicine.
Skin problems
Contact a doctor immediately if you get a rash. Severe and life-threatening skin and hypersensitivity reactions have been reported in some patients taking this medicine.
Other medicines and Isentress
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Isentress may interact with other medicines.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take:
- gastric acid neutralizing drugs (agents that counteract or neutralize the acid in the stomach to reduce indigestion and heartburn). It is not recommended to take Isentress with certain stomach acid neutralizing medicines (those containing aluminum and / or magnesium ). Talk to your doctor about other stomach acid neutralizing drugs you can take.
- iron salts (used to treat and prevent iron deficiency or anemia ). You should wait at least two hours between taking iron salts and taking Isentress, as these medicines may reduce the effect of Isentress.
- rifampicin (a medicine used to treat certain infections , such as tuberculosis ), as it can lower the levels of Isentress. Your doctor may consider increasing your dose of Isentress if you are taking rifampicin.
Ice interest with food and drink
See section 3.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Women with HIV should not breast-feed because their infants may be infected with HIV through breast milk. Talk to your doctor about the best way to feed your baby.
If you are pregnant or breastfeeding, ask your doctor, pharmacist, or nurse for advice before taking any medicine.
Driving and using machines
Do not use machines, drive or cycle if you feel dizzy after taking this medicine.
Ice concentrate contains lactose and sodium
Lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How to take Isentress
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse. Isentress must be used in combination with other medicines for HIV.
How much to take
Adults
The recommended dose is 1 tablet (400 mg) orally twice daily.
Use for children and adolescents
The recommended dose of Isentress is 400 mg orally, twice daily for adolescents and children weighing at least 25 kg.
Do not chew, crush or divide the tablets as this may alter the level of medicine in your body. This medicine can be taken with or without food or drink.
Isentress is also available as a 600 mg tablet, a chewable tablet, and as granules for oral suspension.
Do not switch between 400 mg tablet, 600 mg tablet, chewable tablet, or granules one for oral suspension without first talking to a doctor, pharmacist, or nurse.
If you take more Isentress than you should
Do not take more tablets than your doctor recommends. Contact your doctor if you have taken too many tablets.
If you forget to take Isentress
- If you miss a dose , take it as soon as you remember.
- However, if it is time for the next dose , skip the forgotten tablet and return to the usual schedule.
- Do not take a double dose to make up for a forgotten dose .
If you stop taking Isentress
It is important that you use Isentress exactly as your doctor advised. Do not change the dose or do not stop taking this medicine without first talking to a doctor, pharmacist, or nurse. Do not stop taking the medicine because:
- It is very important that you take all the HIV medicines that you have been prescribed and at the right time of day. This contributes to the drugs working better. It also reduces the risk of your medicines ceasing to work against HIV (so-called drug resistance).
- When your Isentress tablets start to run out, be sure to get more from your doctor or pharmacist. The reason is that it is very important that you do not go without the medicine, even if it is only for a short time. A short break in the medication may be enough to increase the amount of virus in the blood. This may mean that HIV – the virus et can develop resistance to ISENTRESS and become harder to treat.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are -these are less common (may affect less than 1 in 100 people)
Contact a doctor immediately if you notice any of the following:
- herpes infections including shingles
- anemia , even those caused by low iron levels
- signs and symptoms of infection or inflammation
- psychological disorder
- suicide intention or attempt
- gastric inflammation
- hepatitis
- liver failure
- allergic rash
- some kidney problems
- drug intake in larger amounts than recommended
Contact a doctor immediately if you notice any of the side effects listed above.
Common (may affect less than 1 user in 10):
- decreased appetite
- difficulty sleeping, abnormal dreams, nightmares, abnormal behavior, feeling of deep sadness and worthlessness
- dizziness, headache
- dizziness
- flatulence, abdominal pain, diarrhea, increased gas in the stomach or intestines, nausea, vomiting, indigestion, belching
- different types of rash (occurs more often in combination with darunavir)
- fatigue, unusual tiredness or weakness, fever
- elevated liver levels during blood tests, abnormal white blood cells , elevated levels of blood fats, elevated levels of enzymes from the salivary glands or pancreas
Uncommon (may affect less than 1 user in 100):
- infection of the hair follicles, influenza , skin infection due to virus , vomiting or diarrhea due to infection , upper respiratory tract infection, abscess in lymph node
- warts
- pain in the lymph nodes, low number of white blood cells that fight infection , swollen glands in the neck, armpits and groin
- allergic reaction
- increased appetite, diabetes , elevated levels of cholesterol and fatty acids in the blood, high blood sugar levels, excessive thirst, severe weight loss, high blood fats (such as cholesterol and triglycerides ), body fat disorders
- anxiety, confusion, depression, mood swings, panic attack
- memory loss, pain in the hand due to pressure on a nerve, lack of attention, dizziness when standing up quickly, taste changes, increased sleepiness, lack of energy, forgetfulness, migraine headaches, loss of sensation, numbness or weakness in arms and / or legs, crawling , drowsiness, tension headaches, tremors, poor sleep quality
- visual disturbances
- buzzing, hissing, whistling, ringing or other persistent sounds in the ears
- palpitations, slow heartbeats, fast or irregular heartbeats
- hot flashes, high blood pressure
- hoarse, raspy or strained voice, nosebleeds, nasal congestion
- upper abdominal pain, rectal discomfort, constipation, dry mouth , heartburn, swallowing pain, inflammation of the pancreas, ulcers or tenderness in the stomach or upper intestine, bleeding from the rectum, abdominal discomfort, gingivitis, swelling, redness and redness
- fat storage in the liver
- acne , unusual loss or thinning of the hair, reddening of the skin, unusual distribution of fat on the body which can mean reduced fat on the legs, arms and face as well as increased belly fat, excessive sweating, night sweats, thickened skin with itching due to repeated itching, sores on the skin , dry skin
- joint pain, painful joint disease, back pain, skeletal / bone pain, muscle soreness or weakness, neck pain, pain in arms or legs, inflammation in tendon attachments, decreased amount of bone minerals
- kidney stones , increased need to urinate at night, kidney cyst
- difficulty getting an erection , breast augmentation in men, menopausal symptoms
- chest discomfort, chills, facial swelling, nervousness, general malaise, lump in the throat, swollen hands, ankles or feet, pain
- low white blood cell count , low platelet count (a type of cell that causes blood to coagulate), blood tests that show impaired kidney function, high blood sugar, high levels of muscle enzymes in the blood, sugar in the urine, red blood cells in the urine, weight gain, increased waist circumference, low blood protein (albumin), prolonged coagulation time
Additional side effects are in children and adolescents
- hyperactivity
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Isentress
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the can and carton after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is raltegravir. Each film-coated tablet contains 400 mg of raltegravir (as potassium ).
The other ingredients are lactose monohydrate, microcrystalline cellulose, anhydrous dibasic calcium phosphate, hypromellose 2208, poloxamer 407, sodium stearyl fumarate, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide, and black iron oxide.
What the medicine looks like and contents of the pack
The film-coated tablet is oval, pink, and marked with “227” on one side.
Two pack sizes are available: packs containing 1 can of 60 tablets and multipacks of 3 cans of 60 tablets each.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
| Marketing Authorization Holder and Manufacturer | |
| Merck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands |
Contact the representative of the marketing authorization holder to find out more about this medicine:
| ASKMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com | LTUAB Merck Sharp & DohmeTel .: +370 5 278 02 47msd_lietuva@merck.com |
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| DKMSD Danmark ApSTel: +45 4482 4000dkmail@merck.com | MTMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com |
| THEMSD Sharp & Dohme GmbHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de | NLMerck Sharp & Dohme BVTel: 0800 9999000 (+31 23 5153153)medicalinfo.nl@merck.com |
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